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FDA Clears Intuitive Da Vinci Surgical Robot For Prostatectomy

The da Vinci SP surgical robot. [Image from Intuitive]Intuitive Surgical (Nasdaq: ISRG) + announced today that the FDA cleared its da Vinci SP surgical robot for simple prostatectomy.

The clearance, which includes prostatectomy as a representative procedure, expands da Vinci SP's (single-port) available urologic surgical procedures. Sunnyvale, California-based Intuitive's surgical robot now offers the removal of an enlarged prostate blocking urine flow with this procedure.

In the same action, the FDA cleared da Vinci SP for the transvesical approach to simple and radical prostatectomy. With this procedure, the surgeon removes the entire prostate gland, most often for those diagnosed with prostate cancer.

The da Vinci system offers robot-assisted technology for deep and narrow access to tissue in the body. Intuitive's da Vinci system is considered the gold standard in robot-assisted laparoscopic surgery. However, da Vinci SP, while cleared in the U.S. For urology and transoral otolaryngology procedures, does not have clearance for general laparoscopic procedures. The system holds marketing authorization in Japan and Korea for a number of procedures across several disciplines.

It features three multi-jointed, wristed instruments and a fully wristed 3D high-definition camera. The instruments and camera emerge through a single cannula and triangulate around the target anatomy at the distal tip. This helps to avoid external instrument collisions that can occur in narrow surgical workspaces.

"The addition of simple prostatectomy and the transvesical approach to prostatectomy to the da Vinci SP clearances expands the existing urology indication for SP," said Intuitive Chief Medical Officer Dr. Myriam Curet. "There is a growing body of clinical evidence on the use of the SP system, and we look forward to continuing our efforts to safely advance minimally invasive surgery."


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    • Intuitive Receives FDA Clearance Of Da Vinci SP For Simple Prostatectomy

    The MarketWatch News Department was not involved in the creation of this content.

    SUNNYVALE, Apr 28, 2023 (GLOBE NEWSWIRE via COMTEX) -- SUNNYVALE, Calif., April 28, 2023 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ: ISRG), a global technology leader in minimally invasive care and pioneer of robotic-assisted surgery, announced that the Food and Drug Administration recently cleared the da Vinci SP surgical system for simple prostatectomy as a representative procedure, which expands the urologic surgical procedures cleared by FDA.

    Simple prostatectomy is a surgical procedure often used in patients with benign prostatic hyperplasia (BPH) or enlarged prostate. In this procedure, the surgeon removes the part of an enlarged prostate that is blocking the flow of urine.

    In the same action, the FDA cleared the da Vinci SP surgical system for transvesical approach to simple and radical prostatectomy using the da Vinci SP.

    In radical prostatectomy, the surgeon removes the entire prostate gland, most often for patients who have been diagnosed with prostate cancer.

    "The addition of simple prostatectomy and the transvesical approach to prostatectomy to the da Vinci SP clearances expands the existing urology indication for SP," said Intuitive's Chief Medical Officer Myriam Curet, M.D.

    "There is a growing body of clinical evidence on the use of the SP system, and we look forward to continuing our efforts to safely advance minimally invasive surgery," said Curet.

    The da Vinci SP system provides surgeons with robotic-assisted technology designed for deep and narrow access to tissue in the body. The ability to enter the body through a single, small incision or through a natural orifice can provide a minimally invasive experience for complex procedures.

    The da Vinci SP system includes three, multi-jointed, wristed instruments and a fully wristed three-dimensional (3D), high-definition (HD) camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy at the distal tip to avoid external instrument collisions that can occur in narrow surgical workspaces.

    The system enables flexible port placement and excellent internal and external range of motion (e.G., 360-degrees of anatomical access) through the single SP arm. Surgeons control the fully articulating instruments and the camera on the da Vinci SP system, which uses the same surgeon console as the da Vinci X and Xi systems.

    Da Vinci SP can be used in Japan and Korea for a number of procedures across several disciplines.

    The FDA has cleared SP in the U.S. For urology and transoral otolaryngology procedures, but it is not indicated for use in general laparoscopic surgery procedures.

    SP is part of Intuitive's portfolio of surgical systems, now on its fourth generation of innovative technology. The da Vinci X and Xi are Intuitive's multi-port surgical systems.

    About IntuitiveIntuitive (Nasdaq: ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic surgery. Our ground-breaking technologies include the da Vinci surgical system and the Ion endoluminal system. Digital intelligence allows us to unite our advanced systems, progressive learning, and value-enhancing services to help physicians and their teams optimize care delivery to support the best outcomes possible. At Intuitive, we envision a future of care that is less invasive and profoundly better, where diseases are identified early and treated quickly, so patients can get back to what matters most. For more information, please visit: https://www.Intuitive.Com/

    Contact:Peper Long202 997 7373

    COMTEX_430483165/2471/2023-04-28T08:00:39

    Is there a problem with this press release? Contact the source provider Comtex at editorial@comtex.Com. You can also contact MarketWatch Customer Service via our Customer Center.

    (C) Copyright 2023 GlobeNewswire, Inc. All rights reserved.

    The MarketWatch News Department was not involved in the creation of this content.





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